400 FAQs on Good Clinical Practice
Product News Apr 04, 2006
Recommended reading for new recruits to the pharmaceutical business this month is Good Clinical Practice, a pocket guide to Good Clinical Practice requirements in drug, biologics and device clinical trials.
The pocket book guide is presented in question and answer format and covers 400 frequently asked questions about the conduct of clinical trials. The recommendation comes from online pharma business bookshop, Piribo Ltd.
In the wake of the unprecedented adverse reactions experienced by all six triallists given the new TeGenero investigational drug this month, there has inevitably been considerable conjecture about the causes of the events in this trial. This book is an accessible introduction to the regulations governing clinical trials.
There are over 60 companies currently engaged in the development of drugs based on monoclonal antibodies, which was the class of drug involved in this trial. Six lead drugs are in Phase III and six in Phase II.
Further titles of possible interest to R&D scientists who might want to update on clinical trials in this area is New Directions in Monoclonal Antibodies, and for the latest strategies using conjugated or chimeric MAbs as anticancer therapies, there is Improved Monoclonals On The Rise, one of nearly 100 books and industry reports available form Piribo on the subject.